- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04369118
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection (CTS-POP)
Efficacy Study of a Selective Chest Wall Restriction Belt in Postoperative of Lung Resection. A Multicenter, Prospective, Controlled, Randomized Study With Stratification on the Surgical Approach, Open With a Blind Analysis
The objective of this study is to evaluate the efficacy of a new medical device in post-surgery of lung resection. The principle of this new device is based on selective chest wall restriction. This new modality of chest wall restriction is evaluated on patients in post-surgery for lung cancer.
The hypothesis is that the use of this medical device would reduce the postoperative pain and increase the efficacy of cough and expectoration. The evolution of the operated patient would be better.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The present study is the first evaluation of the efficacy of a selective chest wall restriction belt.
The efficacy will be estimate on forced expiratory volume in one second (FEV1) at D3 by comparing 2 groups: a control group of patients with conventional follow-up and an experimental group of patients with conventional follow-up and a daily wear of the selective chest wall restriction belt after surgery.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gil MD Frey, PhD
- Phone Number: 0033 +33 4 76 76 54 75
- Email: GFrey@chu-grenoble.fr
Study Contact Backup
- Name: Isabelle BOUDRY, PhD
- Phone Number: +33 4 76 76 66 45
- Email: iboudrt@chu-grenoble.fr
Study Locations
-
-
-
Bobigny, France, 93000
- Not yet recruiting
- Assistance Publique Hôpitaux de Paris, Hôpital Avicenne
-
Contact:
- Emmanuel Pr MARTINOD, PhD
- Phone Number: 0033 +33 1 48 95 52 31
- Email: emmanuel.martinod@aphp.fr
-
Bron, France, 69500
- Not yet recruiting
- Hopital Louis Pradel
-
Contact:
- François Pr TRONC, PhD
- Phone Number: 0033 +33 4 72 35 74 64
- Email: francois.tronc@chu-lyon.fr
-
Grenoble, France, 38043
- Recruiting
- Chu Grenoble Alpes
-
Contact:
- Gil MD Frey, PhD
- Phone Number: 0033 +33 4 76 76 54 75
- Email: GFrey@chu-grenoble.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria :
- Patients with segmentectomy or lobectomy for lung cancer or lung cancer suspicious,
- Surgical approach : video-assisted thoracic surgery (VATS) or thoracotomy,
- Patients affiliated to social security or similarly regime,
- Patients who gave their consent to participate in the study.
Exclusion Criteria :
- Patients with outcomes of the pulmonary function test at the preoperative assessment : forced expiratory volume in one second (FEV1) or diffusing capacity of the lung for carbon monoxide (DLCO) > 45% predicted post-operative values and VO2max (maximal oxygen consumption) between 10 and 12 ml/kg/min,
- Patients with a waist size > 120 cm
- Patients with medical treatment for chronic pain (neuropathic pain,…)
- Patients with tuberculosis or other pulmonary infectious pathology proven (aspergillosis, lung abscess, actinomycosis,…),
- Patients carrying a resistant germs or extended-spectrum beta-lactamase (ESBL),
- Paraplegic patients
- Patients with a diagnosed, progressive and/or uncontrolled neurological disease
- Patients with a progressive psychosis or a serious psychotic history (hospitalization)
- Patients who are in exclusion period of another interventional study
- Protected person referred to in Articles L1121-5 to L1121-8 of the Code of Public Health
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conventional follow-up+chest wall restriction belt
Patients in this group benefit from conventional post-operative follow-up and wear the selective chest wall restriction belt in parallel.
Patients in this group benefit from conventional post-operative follow-up .
From Day 1 to Month 1
|
Patients in this group benefit from conventional post-operative follow-up
Patients in this group benefit from conventional post-operative follow-up.
The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.
|
Active Comparator: conventional postoperative follow-up
Patients in this group benefit from conventional post-operative follow-up .
From Day 1 to Month 1
|
Patients in this group benefit from conventional post-operative follow-up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of forced expiratory volume in one second (FEV1) between the two groups.
Time Frame: 3 days
|
Comparisons of forced expiratory volume in one second (FEV1) between the two groups at Day 3. The value of FEV1 is standardized with pre-operative one.
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparisons of pulmonary function test between the two groups
Time Frame: 1 month
|
Comparisons of pulmonary function test ( forced expiratory volume in one second (FEV1), Forced vital capacity (FVC)) between the two groups.
They are expressed as Liters.
Before surgery, all days from Day 2 to the patient's exit from hospital (max Day 6) and at the follow-up visit at Month 1.
Each value is standardized with pre-operative one.
|
1 month
|
Comparisons of Peak expiratory flow at cough between the two groups
Time Frame: 1 month
|
Comparisons of Peak expiratory flow at cough (PEF) between the two groups.
It is expressed as Liters per second.
Before surgery, all days from Day 2 to Day 6 and at the follow-up visit at Month 1.
Each value is standardized with pre-operative one.
|
1 month
|
Pain evaluation at rest and during cough: ENS scale
Time Frame: 1 month
|
The patient pain is evaluated using the ENS (Echelle Numérique Standard; standard digital scale, score between 0 to 10) for the two groups.
The pain is evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
|
1 month
|
Qualification of cough
Time Frame: 10 days
|
The cough is classified with this scale : 0-dry cough; 1-productive cough without expectoration; 2-productive cough with expectoration; 3-productive cough with important and/or difficult expectoration.
It's qualified for the two groups all days from Day 2 to the patient's exit from hospital.
|
10 days
|
Characterization of analgesic treatment.
Time Frame: 1 month
|
The analgesic drugs are characterized by their class, dose and number of dose taken in the two groups.
These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
|
1 month
|
Identification of using aerosol therapy, antibiotic therapy and loco-regional anaesthesia
Time Frame: 1 month
|
Use of aerosol therapy (yes/no) and class of drugs.
Use of antibiotic therapy (yes/no), type of drugs and expected duration of treatment.
Use of loco-regional anaesthesia (yes/no), modality of administration and type of drugs.
These elements are evaluated all days from Day 2 to the patient's exit from hospital, at the weekly phone follow-up until Month 1 and at the follow-up visit at Month 1.
|
1 month
|
Number and classification of post-surgery complications
Time Frame: 1 month
|
Number and classification of post-surgery complications.For the two groups from Day 1 to the follow-up visit at Month 1.
|
1 month
|
The length of hospital stay
Time Frame: 10 days
|
The length of hospital stay in days for the two groups.
|
10 days
|
Quantification of the quality of life evaluated with the EQ-5D-5L questionnaire
Time Frame: 1 month
|
The EQ-5D is a generic preference-based measure that indirectly measures the utility for health that generates an index-based summary score based upon societal preference weights.
The EQ-5D-5L consists of 6 items that cover 5 main domains (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a general visual analog scale (VAS) for health status.
Each item has 5 response levels ranging from level 1 (no problem or none) to level 5 (unable to perform activity).
The VAS ranges from 0 (worst health status) and 100 (best health status).
Comparison between the two groups preoperatively, at the patient's exit from hospital, at Day 15 during the phone follow-up and at the follow-up visit at Month 1.
|
1 month
|
Consumption of hospital care
Time Frame: 1 month
|
Comparions of the number of the consumption of hospital care (medical acts and consultations, rehospitalization) between the two groups from Day 1 to the follow-up visit at Month 1.
|
1 month
|
Evaluation of medical device usability for patient
Time Frame: 1 month
|
Only for the medical device's group.
|
1 month
|
Evaluation of medical device usability for caregivers
Time Frame: 1 month
|
Only for the medical device's group.
This questionnaire uses Likert scales from 0 to 10 to evaluate each use step ofthe medical device, closed-ended questions and open questions fr comments.
It will be asked at the end of the clinical study at each caregiver.
|
1 month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 38RC19.102
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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